Virtual Town Hall
FDA Final CSA Guidance Released: The Journey, Changes, & What It Means Now
Nov 13, 2025, 11:00 AM – 12:30 PM EST
The FDA’s Final CSA Guidance represents a significant step in modernizing validation across the industry. While it brings clarity, many questions remain about interpretation, practical application, and alignment with existing quality frameworks.
To address these, the FICSA Team, collaborating with the FDA since 2015, premiered a town hall on November 13, 2025, 11:00 AM–12:30 PM EST, where members of the team answered the questions submitted by the registrants and shared key updates and practical guidance.
About FICSA (FDA Industry CSA) Team
FICSA Team, a collaborative industry group that has worked alongside the FDA since 2015 to shape the evolution of Computer Software Assurance (CSA). Through collaboration, education, and open dialogue, FICSA continues to bridge regulatory intent with practical, risk-based validation strategies that drive innovation, compliance, and digital transformation across the life sciences ecosystem.
FDA Industry CSA (FICSA) Team
AWS HC & LIFE SCIENCES
Senthil Gurumoorthi
EDWARDS LIFE SCIENCES
Andy Lee
GETINGE
Francisco Vicenty
FICSA ADVISORY
Paul Sumner
INSULET
Lou Poirier
PHILLIPS
Pat Baird
Fresenius Medical Care
Marc Koetter
JOHNSON AND JOHNSON
Reggie George
ROCHE
Thorsten Ruehl
GILEAD
Ken Shitatmoto
MDIC
Joseph Sapeiente
SIEMENDS DIGITAL INDUSTRIES